Virtual Reality-Supported Psychosocial Care for Women After Perinatal Loss
NCT ID: NCT07124897
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-08-20
2026-08-01
Brief Summary
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The main questions it aims to answer are:
Does VR-supported psychosocial care reduce depression, anxiety, stress, perinatal grief, and postpartum depression compared to psychosocial care without VR support?
Researchers will compare two groups:
VR-supported psychosocial care Psychosocial care without VR support
Participants will complete baseline psychosocial assessments during hospital admission, receive psychosocial nursing care based on Swanson's Theory of Caring - with or without VR support - during hospitalization, take part in follow-up interviews on Day 7 and Day 30 after discharge, and continue the psychosocial care process at home, including practicing breathing exercises, keeping a daily journal, and receiving supportive information about coping after perinatal loss.
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Detailed Description
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Psychosocial nursing care for women during this period plays a critical role; however, innovative approaches are needed to enhance its effectiveness. Virtual reality (VR) technology provides an immersive environment that can promote relaxation, distract from distressing thoughts, and increase engagement in therapeutic activities. Integrating VR into psychosocial care may help address the complex emotional needs of women following perinatal loss.
This study will evaluate VR-supported psychosocial nursing care, based on Swanson's Theory of Caring, on the psychosocial health outcomes of women aged 18 years and older who have experienced perinatal loss. The intervention includes both educational content addressing physical and reproductive health needs and VR content designed to support psychosocial well-being (360° videos, e.g., forest, seaside), combined with voice-guided breathing exercises, affirmations, and guided relaxation practices.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The VR\_PSYCARE group (experimental arm) receives VR-supported psychosocial nursing care based on Swanson's Theory of Caring, in addition to routine hospital care.
The NONVR\_PSYCARE group (control arm) receives psychosocial nursing care based on the Swanson's Theory of Caring, without VR, in addition to routine hospital care.
The intervention consists of multiple phases: baseline assessment during hospitalization, face-to-face and at-home psychosocial care, and follow-up via telephone on Day 7 and Day 30 after discharge. Psychological outcomes-including depression, anxiety, stress, and grief-are measured using validated scales. Randomization ensures unbiased allocation, and the parallel design enables a direct comparison between the two intervention arms.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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VR_PSYCARE: VR-Supported Psychosocial Care + Routine Care
Participants receive psychosocial nursing care based on Swanson's Theory of Caring, supported by VR, in addition to routine hospital care. The intervention includes face-to-face and at-home psychosocial care and telephone follow-up on Day 7 and Day 30 after discharge. VR content has two main components: (1) educational videos and multimedia materials addressing physical and reproductive health needs after perinatal loss, and (2) psychosocial content using 360° VR videos with guided breathing exercises, affirmations, and relaxation practices. This group is supported through follow-up calls and the continuation of at-home psychosocial care, including encouragement to practice breathing exercises, keep a daily journal, and receive supportive postpartum information.
VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring
This intervention involves psychosocial nursing care based on Swanson's Theory of Caring, supported by VR technology. It is applied to women experiencing perinatal loss, aiming to reduce grief, anxiety, depression, and stress, postpartum depression, and to enhance psychosocial well-being. The care is delivered face-to-face during hospitalization and includes emotional support, active listening, presence, and empathy, aligned with the core concepts of Swanson's theory. The VR component consists of immersive, calming 360-degree visual environments that are integrated into the care sessions to promote emotional regulation. The intervention continues with structured psychosocial support via telephone on day 7 and day 30 after discharge.
NONVR_PSYCARE: Psychosocial Care + Routine Care
Participants receive psychosocial nursing care based on Swanson's Theory of Caring, without VR, in addition to routine hospital care. The intervention includes face-to-face and at-home psychosocial care and telephone follow-up on Day 7 and Day 30 after discharge. This group is supported through follow-up calls and the continuation of at-home psychosocial care, including encouragement to practice breathing exercises, keep a daily journal, and receive supportive postpartum information.
Psychosocial Nursing Care Based on Swanson's Theory of Caring
This intervention involves psychosocial nursing care based on Swanson's Theory of Caring, without the use of VR. It is delivered to women who have experienced perinatal loss, aiming to support emotional healing and reduce psychological symptoms such as grief, anxiety, depression, stress, and postpartum depression. The intervention is provided face-to-face during hospitalization and focuses on presence, listening, empathy, and emotional support in alignment with Swanson's caring processes. Follow-up support is also provided via telephone calls on day 7 and day 30 after discharge, continuing the psychosocial care process without any technological enhancement.
Interventions
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VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring
This intervention involves psychosocial nursing care based on Swanson's Theory of Caring, supported by VR technology. It is applied to women experiencing perinatal loss, aiming to reduce grief, anxiety, depression, and stress, postpartum depression, and to enhance psychosocial well-being. The care is delivered face-to-face during hospitalization and includes emotional support, active listening, presence, and empathy, aligned with the core concepts of Swanson's theory. The VR component consists of immersive, calming 360-degree visual environments that are integrated into the care sessions to promote emotional regulation. The intervention continues with structured psychosocial support via telephone on day 7 and day 30 after discharge.
Psychosocial Nursing Care Based on Swanson's Theory of Caring
This intervention involves psychosocial nursing care based on Swanson's Theory of Caring, without the use of VR. It is delivered to women who have experienced perinatal loss, aiming to support emotional healing and reduce psychological symptoms such as grief, anxiety, depression, stress, and postpartum depression. The intervention is provided face-to-face during hospitalization and focuses on presence, listening, empathy, and emotional support in alignment with Swanson's caring processes. Follow-up support is also provided via telephone calls on day 7 and day 30 after discharge, continuing the psychosocial care process without any technological enhancement.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Being 18 years of age or older
* Having access to a smartphone and the internet
* Having experienced a pregnancy loss at ≥20 weeks of gestation
Exclusion Criteria
* Having a diagnosed psychiatric disorder
* Having a visual or hearing impairment
* Becoming pregnant through infertility treatment
* Inability to speak or understand Turkish
18 Years
FEMALE
No
Sponsors
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Duygu Dişli Çetinçay
OTHER
Responsible Party
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Duygu Dişli Çetinçay
Lecturer, RN, MSc, PhD Student
Principal Investigators
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Duygu Dişli Çetinçay, RN, MSc
Role: PRINCIPAL_INVESTIGATOR
Haliç University
Locations
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Başakşehir Çam and Sakura City Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Köneş, M. Ö., Mecdi Kaydirak, M., Aslan, E., & Yildiz, H. (2017). Perinatal Yas Ölçeği (33 maddeli Kısa Sürüm): Türkçe geçerlilik ve güvenilirlik çalışması. Anadolu Psikiyatri Dergisi, 18(3), 231-236. doi: 10.5455/apd.234509.
Toedter LJ, Lasker JN, Janssen HJ. International comparison of studies using the perinatal grief scale: a decade of research on pregnancy loss. Death Stud. 2001 Apr-May;25(3):205-28. doi: 10.1080/07481180125971.
Sarıçam, H. (2018). The Psychometric Properties of Turkish Version of Depression Anxiety Stress Scale-21 (DASS-21) in Community and Clinical Samples. Journal of Cognitive-Behavioral Psychotherapy and Research, 7(1), 1.
Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.
Chiu PL, Li H, Yap KY, Lam KC, Yip PR, Wong CL. Virtual Reality-Based Intervention to Reduce Preoperative Anxiety in Adults Undergoing Elective Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340588. doi: 10.1001/jamanetworkopen.2023.40588.
Kersting A, Wagner B. Complicated grief after perinatal loss. Dialogues Clin Neurosci. 2012 Jun;14(2):187-94. doi: 10.31887/DCNS.2012.14.2/akersting.
Kalanlar B. Hospital Practices for Parents Following Perinatal Loss. Omega (Westport). 2020 Nov;82(1):92-104. doi: 10.1177/0030222818803809. Epub 2018 Oct 3.
Fenstermacher K, Hupcey JE. Perinatal bereavement: a principle-based concept analysis. J Adv Nurs. 2013 Nov;69(11):2389-400. doi: 10.1111/jan.12119. Epub 2013 Mar 4.
Mecdi Kaydirak M, Aslan E. Efficacy of Nursing Support in the Pre- and Postmedical Termination of Pregnancy Phases: A Randomized Study. Omega (Westport). 2021 Nov;84(1):51-68. doi: 10.1177/0030222819877791. Epub 2019 Sep 24.
Demirel G, Ertekin Pinar S, Bilgic D. Anxiety levels and methods of coping with stress of adolescents undergoing their first gynecological examination. J Psychosom Obstet Gynaecol. 2020 Jun;41(2):131-136. doi: 10.1080/0167482X.2019.1643314. Epub 2019 Jul 22.
Engindeniz, A. N., Küey, L., & Kültür, S. (1996). Edinburgh Doğum Sonrası Depresyon Ölçeği Türkçe Formu Geçerlilik ve Güvenilirlik Çalışması. Bahar Sempozyumları, 1, 51-52.
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
Other Identifiers
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30.01.2025-263
Identifier Type: -
Identifier Source: org_study_id
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